GEN News Highlights

A U.S. District Court judge has dismissed the lawsuit to stop federal funding for human embryonic stem cell (hESC) research just a year after he initially temporarily blocked federal funding of hESC studies. That injunction, issued in August 2010, was subsequently overturned and the case remanded back to Chief Judge Royce C. Lamberth this April.

In his 38-page decision in Sherley et al. v. Sebelius et al., Judge Lamberth of the U.S. District Court for the District of Columbia said he was bound by the April 2011 decision of the U.S. Court of Appeals for the D.C. Circuit. That decision sided with NIH against claims that it violated the Dickey-Wicker Amendment of 1996, which says it is illegal to use federal funds for research “in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero.”

NIH persuaded the appeals court that it could interpret Dickey-Wicker to allow the funding of hESC research but forbid funding for hESC derivation. As a result, Judge Lamberth said in his most recent decision for Sherley v. Sebelius, that he ruled against James L. Sherley, M.D., Ph.D., an adult stem cell researcher at Boston Biomedical Research Institute, and Theresa Deisher, Ph.D., managing member and R&D director of AVM Biotechnology.

“While it may be true that by following the Court of Appeals’ conclusion as to the ambiguity of 'research,' this Court has become a grudging partner in a bout of ‘linguistic jujitsu’…such is life for an antepenultimate court,” Judge Lamberth said in his decision.

“Linguistic jujitsu” was the phrase used to describe NIH’s argument by dissenting judges in the appeals court decision. According to that decision, Dickey-Wicker does not unambiguously bar funding for hESC research, “because Dickey-Wicker is written in the present tense, addressing research ‘in which’ embryos ‘are’ destroyed, not research ‘for which’ embryos ‘were destroyed.’”

That language, according to the court, could be read to require NIH to determine whether what is proposed to be funded meets with the amendment’s requirements. By that reading, the appeals court continued, NIH must reject a grant application to support research that includes the derivation of stem cells. But NIH would not be required to consider the research for which the funds were sought to include “acts or processes such as deriving [hESCs] that predated the federally funded research.”

Drs. Sherley and Deisher filed suit against HHS, its Secretary Kathleen Sebelius, NIH, and NIH Director Francis S. Collins M.D., Ph.D., in 2009 after NIH issued its Guidelines on Human Stem Cell Research. Those guidelines were intended to codify President Barack Obama’s Executive Order that lifted restrictions on hESC research enacted by his predecessor, President George W. Bush.

Drs. Sherley and Deisher argued that the NIH guidelines violated both Dickey-Wicker and the Administrative Procedure Act (APA). Drs. Sherley and Deisher contended that NIH violated APA when it disregarded and deemed irrelevant roughly 30,000 comments challenging the ethical and scientific merits of hESC research, contending that the basic issue of funding hESC research was outside the scope of the rulemaking.

Judge Lamberth ruled, however, that “NIH reasonably interpreted Executive Order 13,505 and operated consistently with both it and the APA’s requirements when it disregarded tens of thousands of public comments,” since the policy question of whether to provide federal funds for hESC research wasn’t at issue. As a result, the judge continued, “the co-plaintiffs’ APA claims 'fail as a matter of law.'"

Lawyers for Drs. Sherley and Deisher said in a statement they were weighing their legal options for an appeal.

“Americans should not be forced to pay for experiments that destroy human life, have produced no real-world treatments, and violate federal law,” said Steven H. Aden, senior counsel with the Alliance Defense Fund (ADF), which is dedicated to “protect and preserve religious liberty, the sanctity of life, marriage, and the family. In these tough economic times, it makes no sense for the federal government to use taxpayer money for this illegal and unethical purpose,” Aden added.

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